Celltrion’s Rituximab Recommended for Approval in Europe

Just weeks after Celltrion presented data at the American College of Rheumatology meeting demonstrating that its product CT-P10 is as safe and effective as Rituxan® for the treatment of rheumatoid arthritis (RA), the European Medicines Agency (EMA) received the recommendation to approve the product for use in the EU.

The Committee for Medicinal Products for Human Use sent its recommendation to EMA on December 15. Assuming the regulator grants marketing authorization, CT-P10 will be sold as Truxima™ and will be indicated for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, RA, granulomatosis with polyangiitis GPA, and microscopic polyangiitis.

The originator product in the EU is MabThera®, which was licensed in 1998. If approved, it will be the first CD20-inhibiting monoclonal antibody to reach the market in a biosimilar version.

In other news from Europe: EMA Launches Consulting Pilot for Biosimilar Manufacturers. In what may be a page taken the US Food and Drug Administration’s (FDA’s) playbook, the EMA is offering scientific advice, starting February 2017, for companies seeking to bring a biosimilar to market. As part of the FDA’s biosimilar development program, it meets with manufacturers at various stages to consult on their analytical and clinical testing projects. The EMA’s pilot initiative does seem to be more limited, however, in that it offers a presubmission consultation. The pilot is said to run for up to 6 requests for scientic advice.